1) SOP for Inkjet or Laser Coding

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and instructions for accurately printing batch numbers, expiry dates, and other essential information on capsules or packaging using inkjet or laser coding technology.

3) Scope

This SOP applies to all personnel responsible for operating inkjet or laser coding equipment within the pharmaceutical manufacturing facility.

4) Responsibilities

• Operators are responsible for setting up, operating, and monitoring the inkjet or laser coding equipment according to this SOP.
• Supervisors are responsible for overseeing the coding process and ensuring compliance with specifications.
• Quality Assurance (QA) personnel are responsible for verifying the accuracy and legibility of coded information.

5) Procedure

1. Preparation
   1. Ensure the coding area is clean and free of contaminants that could affect the coding process.
   2. Verify the availability and quality of coding materials, such as ink or toner cartridges.
   3. Check the readiness and functionality of the inkjet or laser coding equipment.
2. Equipment Setup
   1. Set up the inkjet or laser coding equipment according to the batch record or packaging specifications.
   2. Load the appropriate coding templates or programs into the equipment to ensure accurate printing of batch numbers, expiry dates, and other required information.
   3. Adjust coding parameters, such as font size, print position, and print speed, as per the packaging requirements.
3. Coding Process
   1. Place the capsules or packaging materials in the designated position for coding.
   2. Start the coding process and ensure that the equipment prints each item with the correct information.
   3. Monitor the coding operation to verify the legibility and alignment of printed information.
   4. Record coding parameters and any observations in the batch record or coding log.
4. Troubleshooting
   1. If the coding equipment malfunctions or produces unreadable codes, stop the operation immediately.
   2. Identify the root cause of the issue, such as low ink levels or equipment calibration errors.
   3. Take corrective actions based on the troubleshooting guidelines provided by the equipment manufacturer.
   4. Document all troubleshooting steps, deviations, and corrective actions taken.
5. Cleaning and Maintenance
   1. Turn off and clean the coding equipment regularly to prevent build-up of ink or toner residues.
   2. Use approved cleaning agents and procedures as specified in the equipment manual or cleaning SOP.
   3. Perform routine maintenance checks and calibrations to ensure optimal performance of the coding equipment.
   4. Document cleaning and maintenance activities in the equipment logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Batch Record
• Coding Logbook
• Equipment Maintenance Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual for the coding equipment

9) SOP Version

Version 1.0